The present invention relates to an electrical stimulation method and an electrical clinical apparatus including electrode for detecting electromyogram (EMG) signals from or for applying electrical stimulation signals to a body part; and, more particularly, an electrical stimulation method and an electrical clinical apparatus using variant assignment method applied in treatment of dysfunction such as urinary incontinence.
An electrical clinical apparatus has been used in treatment of such dysfunction as urinary incontinence, constipation and fecal incontinence, pain relief, rehabilitation, and frigidity associated with reinnervation of damaged nerve such as pelvic floor muscle. Most electrical clinical apparatus use electromyogram (EMG) signals or current pulses as intensity of EMG is proportional to contractile force of vaginal (anal) muscle while current pulse is effective in nerve reinnervation.
Although the frequency of EMG signals mostly lies in between approx. 20 and 800 Hz emitting higher frequency components than other bio signals, a conventional mechanism of energy transmission method contrarily uses only a few frequencies (12.5 Hz and/or 50 Hz) without using most of the wide range of frequency bandwidth.
FIGS. 1, 2A and 2B illustrate a conventional electrical clinical apparatus. FIG. 1 illustrates frequency movements in an electrical stimulation method using a conventional frequency fixed assignment method, and FIGS. 2A and 2B illustrate electrodes functioning with fixed frequency according to the electrical stimulation method. A pair of metal rings wound around an electrode is called a channel which is an essential requirement of an electrode structure for conducting electric current.
As seen in above figures, in order to apply stimulation with a specific fixed frequency (F1 or F2) repeatedly, a conventional electrical clinical apparatus fixed to a specific frequency such as 12.5 Hz or 50 Hz on a specific channel 210 or 220 of an electrode 200 included therein. Here, the variation factor of the electrode is a regulation of electric current (voltage) based on the ratio between stimulating duration and resting duration.
However, the conventional apparatus had a problem of discomfort the patient had to suffer from when the specific frequency does not fit a patient""s body. Besides, even though an electrical stimulation frequency fits a patient""s body, continuous stimulation onto a certain region with the same fixed frequency involves the problem of discomfort (usually one session of electrical stimulation takes 15xcx9c30 minutes) Electro-physiologically cell of the skin so easily adapt to the frequency that in the treatment thereafter the sense from electrical stimulation become dull, and thus causing discomfort to the patients. Such a problem may directly lead to discontinued exercise or discourage patient""s endeavor on their treatment.
Therefore, the conventional electrical clinical apparatus had therapeutic value only in case of a patient who fits to such a frequency. It is because the patient""s condition vary in terms of age, sex, race, physical constitution and so on. In short, the uniform treatment of various types of patients with only a specific fixed frequency is unreasonable in itself. The electrical stimulation has a therapeutic value of 90% or more when the stimulation fits a patient while it did not show any effects when it did not fit a patient, accordingly, it is true that medical circles regarded electrical stimulation as a kind of inconsistent therapy.
In addition, above-mentioned discomfort or inconsistent therapeutic value was pointed out as the mere side effects of the electrical stimulation in a medical publication titled xe2x80x9cClinical postreproductive gynecologyxe2x80x9d by Samir N. Hajj and Wendy J. Evans (Appleton and Lange, Inc., pages 308, line 25).
In addition to the problems, the conventional electrical clinical apparatus displays in a uniform pattern the target waveforms, being presented to patients, as an assessing tool of one""s own EMG signals, and thus the patients exercising to the display gets to feel tedious, which often makes patient unable to continue pelvic muscle exercise or EMG biofeedback exercise for a sufficient time.
In order to improve above-mentioned problems, the present applicant applied for: the Korean patent application No.98-5998 filed on Feb. 25, 1998, entitled xe2x80x9cUrinary Incontinence Therapeutic Apparatus using EMG Envelope Signalxe2x80x9d; the Korean patent application No.98-29206 filed on Jul. 21, 1998, entitled xe2x80x9cElectrical Apparatus for Medical Treatment using EMG Envelope Signalxe2x80x9d, claiming domestic priority based on the Korean patent application file No.98-5998; The Korean patent application No.99-4237 filed on Feb. 8, 1999, entitled xe2x80x9cElectrical Clinical Apparatus including Protective Circuit.xe2x80x9d
An object of the present invention is to provide an electrical clinical apparatus and electrical stimulation method for enabling consistent treatment without discomfort as well as for solving problems caused by use of only a few fixed frequencies.
In accordance with an aspect of the present invention, there is provided an electrical clinical apparatus including an electrode, which is in contact with a body part or is inserted into a body cavity, for detecting EMG signals thereof or for applying electrical stimulation signals thereto, the electrical clinical apparatus comprising: a central control device for forming a plurality of protocols by converting frequencies of the electrical signals to be applied to a body part, and for generating a plurality of variants by assembling the protocols, and for respectively selecting protocols or variants to be assigned to each channel of said electrode out of the protocols and variants; a memory device for storing the protocols or variants produced by said central control device, or for re-inputting the stored protocols or variants back to said central control device according to a predetermined program; and an output device for outputting the selected protocol or variant to each channel of said electrode, wherein said electrode assigned with the protocols or variants of choice includes a single- or multi-channel in the same or opposite direction of current and wherein the selected protocols or variants are characterized by the same or opposite electric characteristics each other.
In accordance with an embodiment of the present invention, there is provided an electrical clinical apparatus including an electrode, which is in contact with a body part or is inserted into a body cavity, for detecting EMG signals thereof or for applying electrical stimulation signals thereto, the electrical clinical apparatus comprising: a central control device for assigning each channel of said electrode with the protocols or the variants which are inputted through a communication equipment connected externally into said electrical clinical apparatus, wherein the protocols are formed by a conversion of electric signals to be delivered to a said body part in terms of pulse width, duty ratio, intensity/voltage of supplied electric current, burst duration, and inter-burst interval as well as frequencies and the variants are formed by assembling the protocols; and an output device for outputting the assigned protocols or variants by said central control device into each channel of said electrode, wherein said electrode assigned with the protocols or variants includes a single- or multi-channel with the same or opposite direction of electric currents on each channel and wherein the assigned protocols or variants have the same or opposite electrical characteristics each other.
In accordance with another aspect of the present invention, there is provided an electrical stimulation method through an electrical clinical apparatus including an electrode and a central control device for controlling said electrode, wherein said electrode is in contact with a body part or is inserted into a body cavity for stimulating thereto by applying electrical signals, the electrical stimulation method comprising the steps of: a) creating a protocol library and storing the protocol library in said central control device or a memory of the electrical clinical apparatus, wherein the protocol library includes protocols formed by a frequency conversion of electrical signals to be applied to said body part; b) generating a plurality of variants by assembling the protocols stored in said central control device, or for generating combination of the variants by assembling the plurality of variants; and c) stimulating the body part by assigning each channel of said electrode with the protocols or variants, or combination of the variants of same or opposite frequency elements each other, wherein said electrode assigned with the protocols or the variants includes a single- or multi-channel with the same or opposite direction of electric currents on each channel.
In accordance with an embodiment of the present invention, there is provided an electrical stimulation method for use in an electrical clinical apparatus including a central control device for controlling electrical stimulation signals to be delivered to a body part via an electrode, wherein said electrode is in contact with a body part or is inserted into a body cavity for detecting EMG signals thereof or for applying the electrical stimulation signal thereto, and the electrical stimulation method comprising the steps of: a) receiving a protocol library from a communication equipment linked externally with said electrical clinical apparatus and storing the protocol library in said central control device or a memory thereof, wherein the protocol library includes protocols which is formed by a variation of electric signals applied to a body part in terms of pulse width, duty ratio, intensity/voltage of supplied electric current, burst duration, inter-burst interval as well as the frequencies; b) generating a plurality of variants by assembling the protocols stored in said central control device, or for generating combination of the variants by assembling the plurality of variants; and c) stimulating the body part by assigning each channel of said electrode with the protocols or variants, or combination of the variants of same or opposite frequency elements each other, wherein said electrode assigned with the protocols or the variants includes a single- or multi-channel with the same or opposite direction of electric currents on each channel.
In accordance with another embodiment of the present invention, there is provided an electrical stimulation method for use in an electrical clinical apparatus including an electrode and a central control device for controlling electrical stimulation signals, wherein said electrode is in contact with a body part or is inserted into a body cavity for detecting EMG signals thereof or for applying the electrical stimulation signals thereto, the electrical stimulation method comprising the steps of: a) creating a protocol library and storing the protocol library in said central control device, wherein the protocol library includes protocols formed by variation of target waveform signals presented to the body of a patient as a tool for assessing the EMG signals detected by said electrode; b) generating a plurality of variants by assembling the protocols stored in said central control device, or for generating combination of the variants by assembling the plurality of variants; and c) composing a target waveform with a plurality of EMG protocols or EMG variants containing different waveform characteristics each other out of the protocol library stored in said central control device, and for comparing the training goal waveform with a raw EMG waveform detected as a result of the actual exercise of the patients body part with the target waveform.
In accordance with further another embodiment of the present invention, there is provided an electrical stimulation method for use in an electrical clinical apparatus including an electrode and a central control device for controlling an electrode, wherein said electrode is in contact with a patient""s body part or is inserted into a body cavity for stimulation by applying electric signals to the body part, the method comprising the steps of: a) forming a target waveform from a protocol library including EMG protocols, which are formed by modifying EMG signals detected from the body part by said electrode; and b) forming a raw waveform formed by the EMG signal detected from the patient""s actual exercise so that the patient directly compares the target waveform with the raw waveform on a display device.